Octinib 5.4 — Oclacitinib Maleate 5.4 mg, 20 Tablets

Octinib 5.4 is manufactured as film-coated tablets for oral administration in dogs. Each tablet contains:

• Active Ingredient: Oclacitinib maleate — 5.4 mg equivalent to free oclacitinib.
• Excipients: Microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, magnesium stearate.
• Film Coating: Protective coating designed to facilitate swallowing and protect the active ingredient from environmental degradation.

Pharmacodynamics: Oclacitinib is a selective Janus kinase (JAK) inhibitor. It inhibits the function of various cytokines dependent on JAK1 and JAK3 enzyme activity. Cytokines involved in allergic pruritus and inflammation (specifically interleukin IL-31) utilize the JAK-STAT pathway. By inhibiting this pathway, oclacitinib interrupts intracellular signaling, eliminating the sensation of itching and decreasing cutaneous redness and inflammation. It exhibits minimal activity against cytokines involved in hematopoiesis (JAK2-dependent).

Pharmacokinetics: Following oral administration in dogs, oclacitinib maleate is rapidly and well absorbed from the gastrointestinal tract. Peak plasma concentrations (Cmax) are reached within 1 hour. Bioavailability is approximately 89% and is unaffected by food intake. Plasma protein binding is low (approx. 66–69%). Oclacitinib is extensively metabolized in the liver into multiple metabolites. Elimination is predominantly renal (approx. 70%). The terminal elimination half-life (T1/2) is roughly 3–4 hours, requiring twice-daily dosing initially, followed by once-daily maintenance dosing.

Octinib 5.4 mg is indicated for dogs in the following dermatological conditions:

• 🔹 Allergic Dermatitis: Control of pruritus associated with allergic dermatitis of various etiologies (flea allergy dermatitis, food allergy, contact allergy).
• 🔹 Atopic Dermatitis: Control of clinical manifestations of atopic dermatitis in dogs (chronic environmental allergies, pollen, dust mites, etc.).

Octinib 5.4 is strictly for oral administration in dogs. Tablets can be administered directly into the mouth, hidden in food, or placed on the back of the tongue. Food co-administration does not affect bioavailability.

• Recommended Dosage: The initial and maintenance dose is 0.4 to 0.6 mg oclacitinib per kg body weight.
• Administration Schedule:
  — First 14 Days (Induction Phase): Administer twice daily (every 12 hours).
  — Maintenance Phase (After Day 14): Administer once daily (every 24 hours) at the same dosage rate.
• Dosing Guidance (5.4 mg strength): Typically suitable for dogs weighing between 9 kg and 13.5 kg (1 tablet of 5.4 mg per dose according to exact weight and veterinary direction).
• Missed Dose: If a dose is missed, administer it as soon as remembered and resume the established dosing schedule. Do not administer a double dose.

Octinib 5.4 is contraindicated under the following conditions:

• ⛔ Species Restriction: Do not use in cats or other non-canine species. Strictly for use in dogs.
• ⛔ Age Restriction: Do not use in dogs less than 12 months of age.
• ⛔ Body Weight: Do not use in dogs weighing less than 3 kg.
• ⛔ Infections and Immunosuppression: Do not use in dogs with evidence of severe infections, hyperadrenocorticism (Cushing's disease), or active malignant neoplasia. Oclacitinib modulates the immune system and may increase susceptibility to infections and demodicosis.
• ⛔ Hypersensitivity: Hypersensitivity to oclacitinib maleate or any tablet excipients.

Information regarding drug interactions with oclacitinib in veterinary medicine:

• ⚠️ Immunosuppressants and Corticosteroids: Concomitant use with systemic immunosuppressive agents (e.g., cyclosporine) or long-term corticosteroids has not been evaluated and is not recommended due to potential potentiation of immunosuppression.
• ⚠️ Antiparasitics and Vaccines: Oclacitinib can be safely co-administered with antiparasitic treatments (flea, tick, and worm treatments), NSAIDs, and vaccines (exercise routine clinical monitoring during vaccination).

Use of Octinib 5.4 during pregnancy and lactation is restricted:

• Pregnancy and Lactation: The safety of oclacitinib has not been evaluated in pregnant or lactating bitches, nor in breeding male dogs. Use in these categories is contraindicated.
• Breeding Animals: Not recommended for use in dogs intended for breeding.

Octinib 5.4 is generally well tolerated. Potential adverse reactions include:

• 🔴 Gastrointestinal Effects: Diarrhea, vomiting, anorexia (loss of appetite), and mild digestive upset (often self-limiting within the first few days of therapy).
• 🟡 Dermatologic and Infectious Reactions: Increased susceptibility to secondary skin infections (pyoderma), demodicosis development, and papilloma formation.
• 🟠 Systemic and Behavioral Effects: Lethargy, depression, and polydipsia (increased thirst).
• 🟢 Laboratory Alterations: Transient mild decreases in leukocytic parameters (WBC, neutrophils) and serum albumin during prolonged use.

Overdosing oclacitinib can lead to clinical signs of toxicity:

• Symptoms: Prolonged administration at doses exceeding recommended levels may result in progressive alopecia, interdigital cysts, footpad thickening, bacterial skin infections, demodicosis flare-ups, vomiting, diarrhea, and weight loss.
• Management: No specific antidote exists. In cases of overdose, discontinue Octinib 5.4 treatment immediately and provide symptomatic and supportive veterinary care.

Storage conditions for Octinib 5.4:

• 🌡️ Temperature Control: Store in the original packaging in a dry place protected from direct sunlight at temperatures not exceeding 30 °C.
• 👶 Safety Precautions: Keep out of reach of children and domestic animals. Wash hands thoroughly with soap and water after handling tablets.
• ⏳ Expiration: Stamped on the packaging. Do not use past the expiration date. Any split tablet halves should be returned to the blister pack and used promptly.

The manufacturer does not provide comprehensive dedicated protection features, except for the batch number and series. Authenticity verification of Octinib 5.4 relies on standard packaging identifiers:

• 🔍 Batch and Expiry Details: The outer carton displays clearly printed manufacturing details, including Batch No., Manufacturing Date (Mfg. Date), and Expiry Date (Exp. Date).
• 📦 Packaging Quality: Genuine product from Zenex (PawPhilia) features clean printing with orange-white design, accurate "OCTINIB 5.4" typography, and sealed metallic blister foil strips containing 10 tablets each.